This form is required to facilitate a review by El Camino Hospital (ECH) and the Clinical Research Department (CRD) in determining the feasibility of performing research using ECH resources. For an overview of the clinical research activation workflow, see page 8.
Study Information Overview:
Investigator Name:
Industry/Sponsor Name:
Complete Study Title:
Protocol Name (or Number):
Industry Sponsor Authored Investigator Authored
Will the Study include use of any of the following ECH Resources? (check all that apply)
ECH Facilities (MV or LG) ECH Staffing Systems and/or data stored within ECH Records
If none of the above boxes are marked, contact the Director of Clinical Research before completing this form (ryan_schroeder@elcaminohospital.org). ECH approval may not be required.
Full Description of Study (Clinical Question/ Aims/Design/Safety Data):
Type of Study:
Clinical Trial – A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
Chart Review – A type of research design in which pre-recorded, patient-centered data are used to answer one or more research question
Registry – An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose.
Observational – A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in a clinical trial).
Tissue Collection – The collection of any human biological specimen or byproduct obtained from an individual that is sufficient in type and quantity to permit an analysis of its physical or biochemical properties. This definition includes solid tissues, cells, cell cultures, molecules derived from tissues (DNA, RNA, proteins, etc.) and body fluids, and associated data and information.
Nursing Quality – Studies performed to support pursuit of academic degrees and/or department/committee project in the area of nursing quality improvement.
Other –
If Device Study: Pilot/Early Feasibility Pivotal Post Market
Investigational Device (If Investigational: Category A Category B)
FDA Approved for Indication
Phase of Study (for Clinical Trials): N/A
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